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Safety and Efficacy of Reduced Prolonged-release Tacrolimus Exposure in De Novo Kidney Transplantation: A Randomized, Open-label, Pilot Study in Asia—OPTIMIZE Study

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Author(s)
Young Hoon KimYang-Jen ChiangSung-Joo KimMyoung Soo KimSung Bae ParkSheng-Tang WuKazuhiro HoritaYoshihiro NakashimaHongsi JiangDuck-Jong Han
Keimyung Author(s)
Park, Sung Bae
Department
Dept. of Internal Medicine (내과학)
Journal Title
Transplantation Direct
Issued Date
2019
Volume
5
Issue
4
Abstract
Background.
A multicenter, randomized, open-label, parallel group, pilot, 52-week study in Asian countries that assessed the renal function, efficacy, and safety of reduced-exposure versus standard-exposure prolonged-release tacrolimus (PR-T) in adult kidney transplant recipients (KTRs).

Methods.
Posttransplantation, KTRs received PR-T from weeks 0 to 4 (initial dose, 0.2–0.3mg/kg; target trough level, 6–10 ng/mL). At week 4, KTRs were randomized (1:1) to receive reduced-exposure PR-T (target 4–6 ng/mL, weeks 4–12; 3–5 ng/mL, weeks 12–52) or standard-exposure PR-T (target: 6–10 ng/mL, weeks 4–52). Primary end point: estimated glomerular filtration rate (eGFR) over 52 weeks. Secondary end points (week 52) included creatinine clearance, serum creatinine, graft/ patient survival, biopsy-confirmed acute rejection (AR), composite of graft loss/patient death/biopsy-confirmed AR, and steroidresistant AR. Treatment-emergent adverse events were recorded.

Results.
Sixty-six KTRs received PR-T (reduced-exposure, n = 32; standard-exposure, n = 34) and were analyzed. After per-protocol dose adjustment, mean ± standard deviation tacrolimus trough level was lower with reduced- versus standard-exposure PR-T (week 52, 4.5 ± 1.1 ng/mL vs 8.0 ± 2.2 ng/mL). In the reducedversus standard-exposure group, eGFRwas similar atweeks 8 to 52 (overall least-square mean difference, –2.82; 95%confidence interval, −7.91 to 2.27; P = 0.272). At week 52, there was no significant difference in creatinine clearance (P = 0.375) or serum creatinine (P = 0.547) between groups. All grafts/patients survived, no steroid-resistant AR was reported, and 4 and 3 patients had AR in reduced- and standard-exposure groups, respectively. Drug-related treatment-emergent adverse events were reported in 34.4% and 38.2% of patients, respectively.

Conclusions.
Reducing exposure to PR-T resulted in a clinically acceptable short-term safety profile and was generally as effective as standard tacrolimus exposure for Asian patients.
Keimyung Author(s)(Kor)
박성배
Publisher
School of Medicine (의과대학)
Citation
Young Hoon Kim et al. (2019). Safety and Efficacy of Reduced Prolonged-release Tacrolimus Exposure in De Novo Kidney Transplantation: A Randomized, Open-label, Pilot Study in Asia—OPTIMIZE Study. Transplantation Direct, 5(4), e340–e340. doi: 10.1097/TXD.0000000000000877
Type
Article
ISSN
2373-8731
Source
https://insights.ovid.com/crossref?an=01845228-201904000-00004
DOI
10.1097/TXD.0000000000000877
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/41987
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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